MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) ZERO TIP¿; DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number M0063901050

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a zero tip¿ stone retrieval basket was to be used in a procedure performed on an unknown date.According to the complainant, during preparation, a black foreign object was observed to be inside the package.The foreign object was noted to be ¿like dirt¿ and was estimated to be about 2 mm in size.The device was not used in a patient.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

A visual analysis of the returned device found a small piece of foreign matter in between the original device pouch and a generic plastic bag packaging.The seal was intact and sterility was not compromised.The sealed device was packaged in a second layer generic bag at the distribution center, and it is most likely that the foreign matter was inserted during packaging for distribution.Therefore, the most probable root cause is "manufacturing: distribution process".An investigation has been initiated to address this issue.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.The device history record review found the device met all manufacturing specifications.A search of the complaint database revealed that no similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation that a zero tip stone retrieval basket was to be used in a procedure performed on an unknown date.According to the complainant, during preparation, a black foreign object was observed to be inside the package.The foreign object was noted to be ¿like dirt¿ and was estimated to be about 2mm in size.The device was not used in a patient.The procedure was completed with another zero tip stone retrieval basket.There were no patient complications reported as a result of this event.

• Brand Name: ZERO TIP¿
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7123250
• MDR Text Key: 95081613
• Report Number: 3005099803-2017-03793
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 08714729469643
• UDI-Public: 08714729469643
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0063901050
• Device Catalogue Number: 390-105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1